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Chemokine Receptor Antagonist
SX-682 + Decitabine for Myelodysplastic Syndrome
Phase 1
Recruiting
Led By David A Sallman, MD
Research Sponsored by Syntrix Biosystems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
IPSS intermediate-2 risk or high risk and failed treatment following 4 cycles hypomethylating agent
Must not have
Allergy to study drug component.
Any of the following cardiac abnormalities: QT interval > 480 msec corrected using Fridericia's formula, Risk factors for Torsade de Pointes, Use of medication that prolongs the QT interval, Myocardial infarction ≤ 6 months prior to first day of study drug treatment, Unstable angina pectoris or serious uncontrolled cardiac arrhythmia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days in the 28 day cycle 1.
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the safety of a new drug, SX-682, in patients with Myelodysplastic Syndromes. The goal is to find the maximum tolerated dose and identify any dose-limiting toxicities.
Who is the study for?
This trial is for adults with Myelodysplastic Syndromes (MDS) who have not responded to previous treatments. Participants must have an acceptable level of kidney function, be in a relatively stable condition (ECOG ≤ 2), and not be pregnant or breastfeeding. They should also use contraception if applicable and cannot join if they've had certain heart issues, other cancers within the last 3 years, HIV, Hepatitis B/C, or are on specific medications.
What is being tested?
The study is testing SX-682 alone and combined with Decitabine taken orally or intravenously to find the safest dose that can be tolerated without severe side effects. It aims to establish what's called the maximum tolerated dose (MTD) and recommend a Phase 2 dose for further studies.
What are the potential side effects?
Potential side effects may include reactions at the injection site for IV drugs, fatigue, changes in blood counts leading to increased infection risk or bleeding problems. There could also be liver-related issues indicated by elevated enzymes AST/ALT and gastrointestinal symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
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My condition is high-risk and didn't improve after 4 treatments with a specific medication.
Select...
My low or intermediate-1 risk cancer did not respond to specific treatments.
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My condition is low or intermediate-1 risk with 5q deletion, and treatments with lenalidomide did not work for me.
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I am a man and will use the specified contraception if sexually active.
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My kidney function, measured by GFR, is at least 30 ml/min.
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I have been diagnosed with MDS according to WHO standards.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic to one of the components in the study drug.
Select...
I have heart issues like abnormal ECG, recent heart attack, or use heart-related medications.
Select...
I have not had major surgery in the last 4 weeks.
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I do not have any serious or uncontrolled health issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 28 days in the 28 day cycle 1.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days in the 28 day cycle 1.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
SX-682 Dose Limiting Toxicities (DLT)
SX-682 Maximum Tolerated Dose (MTD)
Secondary study objectives
Adverse Events
Participants Experiencing a Treatment Response
SX-682 Delayed Dose Limiting Toxicities
+3 moreSide effects data
From 2023 Phase 1 & 2 trial • 12 Patients • NCT0457458367%
Neutrophil count decreased
67%
Oral hemorrhage
67%
Injection site reaction
67%
Lipase increased
67%
White blood cell decreased
67%
Anemia
67%
Fatigue
33%
Abdominal pain
33%
Edema limbs
33%
Hypokalemia
33%
Lymphocyte count decreased
33%
Memory impairment
33%
Nausea
33%
Upper gastrointestinal hemorrhage
33%
Rectal hemorrhage
33%
Flu like symptoms
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301
Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301
Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: Expansion of SX-682 with decitabine (lower risk patients, naive to hypomethylating agents)Experimental Treatment2 Interventions
Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in lower risk patients who have never received hypomethylating agents.
Group II: Expansion of SX-682 with decitabine (lower risk patients, failed on hypomethylating agents)Experimental Treatment2 Interventions
Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in lower risk patients who failed on hypomethylating agents.
Group III: Expansion of SX-682 with decitabine (higher risk patients, naive to hypomethylating agents)Experimental Treatment2 Interventions
Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in higher risk patients who have never received hypomethylating agents.
Group IV: Expansion of SX-682 with decitabine (higher risk patients, failed on hypomethylating agents)Experimental Treatment2 Interventions
Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in higher risk patients who failed on hypomethylating agents.
Group V: Expansion of SX-682 alone (lower risk patients, naive to hypomethylating agents)Experimental Treatment1 Intervention
Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) in lower risk patients who have never received hypomethylating agents.
Group VI: Expansion of SX-682 alone (lower risk patients, failed on hypomethylating agents)Experimental Treatment1 Intervention
Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) in lower risk patients who failed on hypomethylating agents.
Group VII: Expansion of SX-682 alone (higher risk patients, failed on hypomethylating agents)Experimental Treatment1 Intervention
Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) in higher risk patients who failed on hypomethylating agents.
Group VIII: Dose Escalation of SX-682Experimental Treatment1 Intervention
Escalating oral doses of SX-682 (study drug) of 25, 50, 100, 200 and 400 mg twice-daily (i.e., 50, 100, 200, 400 and 800 mg total each day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2004
Completed Phase 3
~1720
SX-682
2020
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterOTHER
457 Previous Clinical Trials
588,470 Total Patients Enrolled
Syntrix Biosystems, Inc.Lead Sponsor
13 Previous Clinical Trials
656 Total Patients Enrolled
Emory UniversityOTHER
1,700 Previous Clinical Trials
2,604,447 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and am up and about more than half of my waking hours.My condition is high-risk and didn't improve after 4 treatments with a specific medication.I am allergic to one of the components in the study drug.I have heart issues like abnormal ECG, recent heart attack, or use heart-related medications.I haven't had any cancer except for local ones cured in the last 3 years.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.My low or intermediate-1 risk cancer did not respond to specific treatments.I have not received a live-virus vaccine in the last 30 days.I have not had major surgery in the last 4 weeks.My condition is low or intermediate-1 risk with 5q deletion, and treatments with lenalidomide did not work for me.I do not have any serious or uncontrolled health issues.I have not used any blood cell growth boosters in the last 14 days.I am a man and will use the specified contraception if sexually active.My kidney function, measured by GFR, is at least 30 ml/min.I haven't taken any chemotherapy or experimental drugs for MDS in the last 14 days.I have been diagnosed with MDS according to WHO standards.
Research Study Groups:
This trial has the following groups:- Group 1: Expansion of SX-682 with decitabine (higher risk patients, failed on hypomethylating agents)
- Group 2: Expansion of SX-682 alone (lower risk patients, naive to hypomethylating agents)
- Group 3: Expansion of SX-682 with decitabine (higher risk patients, naive to hypomethylating agents)
- Group 4: Dose Escalation of SX-682
- Group 5: Expansion of SX-682 alone (lower risk patients, failed on hypomethylating agents)
- Group 6: Expansion of SX-682 with decitabine (lower risk patients, naive to hypomethylating agents)
- Group 7: Expansion of SX-682 with decitabine (lower risk patients, failed on hypomethylating agents)
- Group 8: Expansion of SX-682 alone (higher risk patients, failed on hypomethylating agents)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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